This study in moral, political, and legal philosophy contends that it is morally impermissible to circumcise male minors without a medical indication (nontherapeutic circumcision). Male minors have a moral anticipatory autonomy right-in-trust not to be circumcised. This right depends on norms of autonomy and bodily integrity. These norms generate three direct non-consequentialist arguments against nontherapeutic circumcision: (1) the loss of nonrenewable functional tissue, (2) genital salience, and (3) limits on a parental right to permanently modify their sons' bodies. (...) An indirect argument holds (4) that if it is morally impermissible to remove the female prepuce (clitoral hood), then it is also morally impermissible to remove the male prepuce (foreskin). Although there is debate across medical cultures, a reasonable understanding supports the claim that nontherapeutic circumcision causes some harms and imposes unwarranted risks on male minors. The overall moral case applies to secular circumcisions and, with some qualifications, to religious circumcisions in Judaism and Islam. Arguments of political philosophy that invoke the freedom of religion, toleration, multiculturalism, and social meaning qualify somewhat, but do not eliminate, the case against circumcising male minors without a medical indication. Nevertheless, the arguments deployed in this study do not warrant legal interference at this time with secular and religious practices of nontherapeutic circumcision. (shrink)

The purpose of this article is to describe the main ethical issues in paediatric nontherapeutic qualitative pain research. It is based on an analysis of the research literature related to ethical issues in research and on experiences from a family interview study focusing on pain assessment and management in children aged 1-6 years. In addition, different views concerning obtaining informed consent from children, as published in the research literature, are compared. Ethical challenges occur during all stages of qualitative research. (...) The risks of emotional distress and possible benefits of the results must be assessed prior to conducting a study. However, risks and harm are difficult to avoid in a study in which the research area, pain, raises emotional distress in both parents and children. The children’s assent and parental permission are both required. It is essential to obtain informed consent from all family members when family research is conducted. Participants’ privacy and confidentiality should be protected during data collection, analysis and publication. Protecting children from harm may be impossible during pain research in which they are required to recall a painful postoperative period. However, after data collection they can be assisted to focus on pleasant activities, for example, by engaging in playful activities with them. Finally, the role of the nurse and the researcher should be carefully assessed, especially in qualitative research, in order to be able to analyse the data and report the findings in an unbiased manner. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent (...) writers misconceive how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)

Hymen construction and nontherapeutic male circumcision are medical nonindicated interventions that give rise to specific ethical concerns. In Europe, hymen construction is generally more contested among medical professionals than male circumcision. Yet, from a standard biomedical framework, guided by the principles of autonomy, beneficence, nonmaleficence, and justice, circumcision of boys is, as this article explains, more problematic than hymen construction. While there is a growing debate on the acceptability of infant circumcision, in the case of competent minors and adults (...) the surgery is not questioned. In the case of hymenoplasty, usually requested by a competent patient, it is recommended to only perform the operation after extensive counseling and if there are compelling conditions. The article further explores why attitudes of medical professionals toward both surgeries diverge and seeks to explain how this is largely informed by gendered and socio-cultural understandings. The arti... (shrink)

Pharmacological cognitive enhancements nontherapeutically improve cognitive functioning, though recent critics have challenged their use by claiming that cognitive success, aided by the use of cognitive enhancement, is less valuable than otherwise. We criticize two recent responses to this objection, due to Carter and Pritchard and Wang, and propose a different response on behalf of proponents of cognitive enhancement that is shown to be more promising.

The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research (...) directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (shrink)

This article proposes a model for regulating use of cognition enhancement drugs for nontherapeutic purposes. Using the method of reflective equilibrium, the author starts from the considered judgment of many citizens that treatments are obligatory and permissible while enhancements are not, and with the application of general principles of justice explains why this is the case. The author further analyzes and refutes three reasons that some influential authors in the field of neuroethics might have for downplaying the importance of (...) justice: (1) Justice applies only to public funds and state action—not to individual choice or corporate actors. (2) “Performance enhancement” does imply questions of justice, while “performance maintenance” does not. (3) There is no sufficient difference between cognition-enhancement drugs and other technologies to warrant the importance of justice for the debate. The challenges are refuted by taking into account the difference between consumption and tool use, and the influence of socioeconomic pressure for widespread use that existing drugs could have on the basic structure of society and equal autonomy of citizens. The analysis of requirements of justice points to a conclusion that introducing economic disincentives for the use of cognition-enhancement drugs would be the most legitimate public policy. With the imposition of taxes, fees, and requirements of additional insurance, the use and indirect coercion to use would be less profitable and less widespread, while additional funds thus created could be allocated to meet basic medical needs and/or education. (shrink)

Male circumcision—partial or total removal of the penile prepuce—has been proposed as a public health measure in Sub-Saharan Africa, based on the results of three randomized control trials showing a relative risk reduction of approximately 60 per cent for voluntary, adult male circumcision against female-to-male human immunodeficiency virus transmission in that context. More recently, long-time advocates of infant male circumcision have argued that these findings justify involuntary circumcision of babies and children in dissimilar public health environments, such as the USA, (...) Australasia and Europe. In this article, we take a close look at the necessary ethical and empirical steps that would be needed to bridge the gap between the African RCTs and responsible public health policy in developed countries. In the course of doing so, we discuss some of the main disagreements about the moral permissibility of performing a nontherapeutic surgery on a child to benefit potential future sexual partners of his. In this context, we raise concerns not only about weaknesses in the available evidence concerning such claims of benefit, but also about a child’s moral interest in future autonomy and the preservation of his bodily integrity. We conclude that circumcision of minors in developed countries on public health grounds is much harder to justify than proponents of the surgery suggest. (shrink)

Opinion about neonatal male circumcision is deeply divided. Some take it to be a prophylactic measure with unequivocal and significant health benefits, while others consider it a form of child abuse. We argue against both these polar views. In doing so, we discuss whether circumcision constitutes bodily mutilation, whether the absence of the child's informed consent makes it wrong, the nature and strength of the evidence regarding medical harms and benefits, and what moral weight cultural considerations have. We conclude that (...) nontherapeutic circumcision of infant boys is a suitable matter for parental discretion. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religion and the Body in Medical ResearchCourtney S. Campbell (bio)AbstractReligious discussion of human organs and tissues has concentrated largely on donation for therapeutic purposes. The retrieval and use of human tissue samples in diagnostic, research, and education contexts have, by contrast, received very little direct theological attention. Initially undertaken at the behest of the National Bioethics Advisory Commission, this essay seeks to explore the theological and religious questions embedded (...) in nontherapeutic use of human tissue. It finds that the “donation paradigm” typically invoked in religious discourse to justify uses of the body for therapeutic reasons is inadequate in the context of nontherapeutic research, while the “resource paradigm” implicit in scientific discourse presumes a reductionist account of the body that runs contrary to important religious values about embodiment. The essay proposes a “contribution paradigm” that provides a religious perspective within which research on human tissue can be both justified and limited.The retrieval and use of human tissue samples for diagnostic, therapeutic, research, and educational purposes represent further developments in scientific study of the human body as a source of medical information. Following the completion of its examination of the ethical and policy issues pertaining to human cloning in the spring of 1997, the National Bioethics Advisory Commission (NBAC) returned to the set of questions for which it had been originally constituted, including ethical issues that arise in human subjects research. One issue that proved controversial for the human genetics subcommittee of NBAC was the scientific, philosophical, and legal status of tissue and other body parts (usually surgical specimens) that had been retrieved from patients (not research subjects) who had given general consent to the use of their body materials for research and educational purposes. The subcommittee addressed questions about the adequacy of general versus specific [End Page 275] consent, the scientific merits of identifiable versus anonymous samples and claims about patient confidentiality, and the justification for patient refusals and requests that the materials be returned to the patient or discarded rather than made available for scientific research. In an effort to better understand the ramifications of research on human tissue, the subcommittee commissioned several background papers that examined these questions from ethical, legal, research, and religious perspectives. What follows is a modified version of the report on religious considerations originally presented to the genetics subcommittee of NBAC.The central question examined in this article is whether tissue banking for purposes of research presents distinctive theological issues or prompts objections from religious communities or scholars. Religious discussion of human organs and tissues has focused largely on donation for therapeutic purposes (what I describe as the “donation paradigm”); hence, there is very little direct consideration of nontherapeutic uses of such tissue. It is possible, however, to describe implications and suggest inferences by considering (1) religious attitudes to the human body and to organs, tissues, and cells removed from the body, and (2) religious discussions of modes of transfer of body parts, such as donations, offerings, sales, and abandonment. By and large, this discussion will reflect themes that emerge from the central Western religious traditions, with some attention given to Eastern and Native perspectives.The Body: Religious Holism, Scientific Reductionism, Private PropertyThe human body as an organic totality has long been the subject of theological reflection and a symbol for religious communities. However, much less attention has been devoted to the religious status of organs, tissues, cells, and DNA. The reflection of religious scholars and communities on the status of body parts has been prompted by the necessity to confront practical questions in personal and public health and in communal life, such as justifications for surgery, autopsies, organ donation, or burial. Scientific and research interest in parts of the body can sometimes conflict with religious values about bodily integrity. Indeed, E. Richard Gold cites the “disparate claims of scientific investigation and religious belief on the body” as the exemplary case of incommensurate values regarding the body. According to Gold (1996, p. 149), “The body, from a scientific viewpoint, is a source of knowledge of physical development, aging, and disease. From a religious perspective, the body is understood [End Page 276] as a sacred object, being created in the image... (shrink)

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. (...) Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children. The first ethical issue raised by these experiments is: did the severity of illness in these children justify their exposure to short and long-term risks? The ethics of the experiments will be evaluated by referring to existing codes of medical research ethics-the Nuremberg Code, the Declaration of Helsinki, and the federal Code of Regulations. The thirteen cases presented will demonstrate that children are being used in ever more speculative experiments, often in the absence of a therapeutic intent, but a significant chance for causing harm and / or discomfort. Some of the experiments were designed to explore the mechanisms of pathology and pharmacological interventions, or the response of neurological brain receptors to chemical provocation ("challenge"). Others were designed to test the safety or efficacy of new drugs, even to test these drugs on healthy children who were hypothesized to be "at risk." Children and adolescents have been subjected to "forced dose titration" experiments that induced a spectrum of severe adverse effects, including insomnia, extreme restlessness, agitation, (akathisia) and self-injurious behavior. FDA reports show that suicide is a significant issue in psychotropic drug trials-in pediatric trials the problem is even greater. The paper aims to demonstrate how the enactment of the Better Pharmaceuticals for Children Act (incorporated into the Food and Drug Administration Modernization Act, FDAMA), set in motion a radical shift in public policy by providing huge financial incentives to pharmaceutical companies to test new or patented drugs in children. Federal policy shifted from one aimed at protecting children by setting limits on permissible research risks, to a policy aimed at broadening the inclusion of children as test subjects. It will be shown how the FDA and the Department of Health and Human Services lifted regulatory restrictions to permit research involving greater than minimal risk to be conducted on healthy children, claiming that all children are potentially "at risk" of a future condition. Children were in this way deprived of regulatory protections. An argument will be made that the approval of nontherapeutic, harmful experiments-such as exposure of toddlers to lead poison-under the current gate keeping system raises serious doubts about the sustainability of institutional review boards (IRBs) as protectors of human research subjects. Children, who are precluded from exercising the adult human's right to informed consent, are being exploited as commodities for commercial ends. It is the position of the author that nothing less than the enactment of a federal law mandating a radical overhaul of the current research review system, with independent checks and balances, will provide children the legal protections they need. Ten specific recommendations are offered to protect children from harmful experiments. (shrink)

Sex reassignment surgery is a therapy for gender dysphoria standardly provided only upon a psychiatric authorization. Transgender scholars criticize this practice as unjustified medicalization and stigmatization of transsexual people. By demanding that sex reassignment surgery is not classified as therapy, they imply it should be classified as some kind of a biomedical enhancement. It is argued in this article that this reclassification is empirically and morally implausible because sex reassignment surgery is incompatible with two major views of enhancement. It is (...) incompatible with the nontherapeutic view because it does not improve or augment, above average, any physical or mental trait or function. It is incompatible with the welfarist view because this view, contrary to the transgender scholars’s demands, is compelled to retain the standard practice of providing sex reassignment surgery in order to ensure the optimal balance between its availability, beneficence, and possible harmfulness. (shrink)

The Hyde Amendment and Roman Catholic attempts to put restrictions on Title X funding have been criticized for being intolerant. However, such criticism fails to appreciate that there are two competing notions of tolerance, one focusing on the limits of state force and accepting pluralism as unavoidable, and the other focusing on the limits of knowledge and advancing pluralism as a good. These two types of tolerance, illustrated in the writings of John Locke and J.S. Mill, each involve an intolerance. (...) In a pluralistic context f where the free exercise of religion is respected, John Locke's account of tolerance is preferable. However, it (in a reconstructed form) leads to a minimal state. Positive entitlements to benefits like artificial contraception or nontherapeutic abortions can legitimately be resisted, because an intolerance has already been shown with respect to those that consider the benefit immoral, since their resources have been coop ted by taxation to advance an end that is contrary to their own. There is a sliding scale from tolerance (viewed as forbearance) to the affirmation of communal integrity, and this scale maps on to the continuum from negative to positive rights. Keywords: church and state, Hyde Amendment, Locke, Mill, religious liberty, Title X funding, toleration CiteULike Connotea Del.icio.us What's this? (shrink)

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes (...) his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes (...) his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

Living related organ transplantation is morally problematic for two reasons. First, it requires surgeons to perform nontherapeutic, even dangerous procedures on healthy donors—and in the case of children, without their consent. Second, the transplant donor and recipient are often intimately related to each other, as parent and child, or as siblings. These relationships challenge our conventional models of medical decisionmaking. Is there anything morally problematic about a parent allowing the interests of one child to be risked for the sake (...) of another? What exactly are the interests of the prospective child donor whose sibling will die without an organ? Is the choice of a parent to take risks for the sake of her child truly free, or is the specter of coercion necessarily raised? (shrink)

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and scientific soundness. However, it (...) also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research and nonclinical biomedical research. In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee. (shrink)

In virtually all the developed countries of the Western world, people are living longer and reproducing less. At the same time, costs for the care of the elderly and infirm continue to rise dramatically. Given these facts, it should come as no surprise that we are experi encing an ever-increasing concern with questions relating to the proper care and treatment of the aged. What responsibilities do soci eties have to their aging citizens? What duties, if any, do grown chil dren (...) owe their parents? What markers should we use to determine one's status as "elderly"? Does treatment of pain in aged patients present special medical and/or moral problems? How can the com peting claims of autonomy and optimal medical care be reconciled for elderly persons who require assisted living? When, if ever, should severely demented patients be included in nontherapeutic clinical tri als? These questions, and others of similar interest to those con cerned with the proper treatment of the aged, are discussed in depth in the articles included in this text. The essays in this volume of Biomedical Ethics Reviews fall loosely into two broad categories. The first four articles-those con tributed by Sheila M. Neysmith, Allyson Robichaud, Jennifer Jackson, and Susan McCarthy-raise general questions concerning the propri ety of Western society'S current mechanisms for dealing with and treat ing elderly citizens. The remaining four articles-those by Simon Woods and Max Elstein, Marshall B. (shrink)

Research in the intensive care unit (ICU) is commonly thought to pose 'serious risk' to study participants. This perception may be at the root of a variety of impediments to the conduct of clinical trials in the ICU setting. Component analysis offers a promising approach to the ethical analysis of ICU research. Because clinical trials commonly involve a mixture of study interventions, therapeutic and nontherapeutic procedures must be analyzed separately. Therapeutic procedures must meet the requirement of clinical equipoise. Risks (...) associated with nontherapeutic procedures must be minimized consistent with sound scientific design, and be deemed reasonable in relation to the knowledge to be gained. When research involves a vulnerable population, such as adults incapable of providing informed consent, nontherapeutic risks are limited to a minor increase over minimal risk. Understood in this way, the incremental risk posed by participation in ICU research may be minimal. This realization has important implications for review by institutional review boards of such research and for the informed consent process. (shrink)

The prelims comprise: Germline Gene Therapy Genetic Enhancements The Genome and the Normative Status of Human Nature Conclusion Notes.

This commentary draws upon the author's experience in bioethics and as a physician, ordained Rabbi, and certified Mohel (a Jewish professional qualified to perform infant male circumcisions (MC)). People's identity and adherence to a religious belief are frequently cited reasons for deciding whether to circumcise their male children. For Jewish and Muslim males, circumcision is considered essential. In this commentary, the author uses his medical, religious, and bioethical knowledge, expertise, and experience to address common arguments used in opposing nontherapeutic (...) male circumcision of minors. In these narratives, half of the parents agreed with circumcision, and half did not. The parents against circumcision cite human rights violations, security, privacy, and bodily integrity issues and refer to circumcision as genital mutilation, while those who agree argue that circumcision should be done for religious reasons to prevent health issues, promote hygiene and cleanness, avoid cancer, or for later sexual enjoyment. After evaluating the evidence, the author states that parents should be free to either consent or decline MC for a son. Though a reoccurring theme in these narratives was for mothers to leave the circumcision decision up to their male partners, the author concludes that women have considerable power regarding the decision. (shrink)

I explain why I think that considerations regarding the opposing rights involved in the practice of circumcision—rights of the individual to bodily integrity and rights of the community to practice its religion—would not help us decide on the desirable policy towards this controversial practice. I then suggest a few measures that are not in conflict with either religious or community rights but that can both reduce the harm that circumcision as currently practiced involves and bring about a change in attitude (...) towards the practice, thus further reducing its frequency. These measures are the compulsory administration of anaesthetics; the banning of the metzitzah b’peh; and having an upper age limit of a few months on nontherapeutic circumcision of minors. I conclude with general considerations on why the steps taken towards the reform of circumcision should be moderate. (shrink)

Suppose we accept prenatal diagnosis and the selective abortion of fetuses that test positive for severe genetic disorders to be both morally and socially acceptable. Should we consider prenatal diagnosis and selective abortion (or other genetic interventions such as preimplantation diagnosis, genetic therapy, cloning, etc.) for nontherapeutic purposes to be acceptable as well? On the one hand, the social aims to promote liberty in general, and reproductive liberty in particular, provide reason for thinking that individuals should be free to (...) make their own decisions about whether or not to employ whatever genetic services might be developed and offered by private enterprise. On the other hand, interventions aimed at enhancement would (in many cases) presumably only be available to those who are financially fortunate. A worry is that unequal access to enhancements that provide competitive advantages to offspring will further and more permanently increase existing unjust disparities between the haves and have-nots. The aim to promote liberty might thus conflict with the social aim of equality. An additional worry is that the development and provision of nontherapeutic genetic interventions would drain limited medical resources away from therapeutic purposes which would ultimately be more fruitful. The promotion of liberty might also thus conflict with the aim to promote aggregate utility. Assuming there is no reason to think that the promotion of liberty should be given absolute priority over both equality and aggregate utility, we need to think more about how to make trade-offs between these three legitimate social aims. (shrink)

This essay explores the plausibility of attempting to justify the imposition of risk on young children, in the course of therapeutic treatment or nontherapeutic research, by an appeal to proxy consent. In particular, Richard McCormick's reliance on this type of defense is examined and rejected, and an alternative basis for determining the justifiability of such treatment is partially sketched – one which avoids any attempt to ‘construct’ consent on the part of the child. CiteULike Connotea Del.icio.us What's this?

A New York court recently struck down state Office of Mental Health regulations governing research involving subjects with impaired decisionmaking capacity. The court held that neither incapacitated adults nor minors could participate in any research protocol that contained a nontherapeutic element, irrespective of possible benefits to the subject or the importance of the knowledge to be gained. Although the decision rested on a technical point of law and dealt only with psychiatric research, the court's holding has significantly broader implications.

Opinion about neonatal male circumcision is deeply divided. Some take it to be a prophylactic measure with unequivocal and significant health benefits, while others consider it a form of child abuse. We argue against both these polar views. In doing so, we discuss whether circumcision constitutes bodily mutilation, whether the absence of the child's informed consent makes it wrong, the nature and strength of the evidence regarding medical harms and benefits, and what moral weight cultural considerations have. We conclude that (...) nontherapeutic circumcision of infant boys is a suitable matter for parental discretion. (shrink)

Opinion about neonatal male circumcision is deeply divided. Some take it to be a prophylactic measure with unequivocal and significant health benefits, while others consider it a form of child abuse. We argue against both these polar views. In doing so, we discuss whether circumcision constitutes bodily mutilation, whether the absence of the child's informed consent makes it wrong, the nature and strength of the evidence regarding medical harms and benefits, and what moral weight cultural considerations have. We conclude that (...) nontherapeutic circumcision of infant boys is a suitable matter for parental discretion. (shrink)

This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to justify the exposure (...) of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. The assent therefore did not provide a valid justification for requesting a blood sample from these children. This study indicates that most children younger than 9 years of age cannot be expected to consent or assent to clinical research in a meaningful way. The current age of 7 years for initiating assent (in addition to parental consent) is possibly not appropriate and should be reconsidered. (shrink)

Few early debates in bioethics invigorated the field to the same extent as the one concerning whether or not young children could be used in nontherapeutic research. Though some of the issues in the debate were never fully settled, a consensus emerged, reflected in the Common Rule—that surrogates could consent to use children in such research, although once the level of risk rises above minimal, additional stipulations are required. Nontherapeutic research on cognitively impaired elderly people raises equally complex (...) ethical issues, but there has been a dearth of debate in the literature about whether such research is ethically permissible. Instead, there have been many published recommendations regarding the circumstances under which such research can occur. (shrink)

The ethical propriety of routine male infant circumcision has been debated in journals of medicine and law for many years. This article explores the issue from historical, medical, and moral perspectives. Two essentially different forms of circumcision (one more drastic than the other) are distinguished. Discussion focuses on the effects of the more radical kind of nontherapeutic surgery on a normal healthy child’s body: whether it constitutes a mutilation, whether it is medically warranted, and whether it is ethically defensible (...) in light of general philosophical principles and Catholic moral doctrine. The conclusion questions the social bias favoring parental choice to circumcise a non-consenting son. National Catholic Bioethics Quarterly 12.1 (Spring 2012): 99–128. (shrink)

Progress in emergency and critical care requires that clinical research be performed on patients who are incapable of granting consent for research participation. Analyses of the ethics of such research have left some questions incompletely answered. Why should we be permitted to expose vulnerable patients to research risks without their consent? In particular, how do we justify research interventions that have no potential benefit for participants (nontherapeutic interventions)? This article presents a moral justification for nontherapeutic interventions in emergency (...) research. By relying on a framework for assessing research risks, and by drawing on the example of pediatric research, this justification is founded in how institutional review boards, and society in general, analyze risk. Our justification for emergency research also suggests additional protections for emergency research participants, including a stringent threshold for research risk, that still permit important research to proceed. (shrink)

More than 24,000 patients await organ transplants and the number is increasing yearly. Living donors are an important source of transplant organs. In this paper, I argue that we can morally justify allowing children to serve as donors. Yet, I also argue that their participation must be restricted in order to prevent their exploitation.The paper is divided into six sections. In the first section, I show why the traditional principles of personal autonomy and beneficence are not adequate morally to justify (...) the participation of children in the nontherapeutic role of organ donor. Next, I argue that the moral justification of the child’s participation must be based on the intimate family relationship which permits activities that would be unacceptable in the public domain. In the third section, I argue that family autonomy ought to be limited by the principle of respect for persons. In the fourth section, I propose five principles to guide the participation of children as organ donors. In section five, I discuss the role of the child in the decision-making process. In section six, I critically examine the criteria for equity in donor selection. (shrink)

More than 24,000 patients await organ transplants and the number is increasing yearly. Living donors are an important source of transplant organs. In this paper, I argue that we can morally justify allowing children to serve as donors. Yet, I also argue that their participation must be restricted in order to prevent their exploitation.The paper is divided into six sections. In the first section, I show why the traditional principles of personal autonomy and beneficence are not adequate morally to justify (...) the participation of children in the nontherapeutic role of organ donor. Next, I argue that the moral justification of the child’s participation must be based on the intimate family relationship which permits activities that would be unacceptable in the public domain. In the third section, I argue that family autonomy ought to be limited by the principle of respect for persons. In the fourth section, I propose five principles to guide the participation of children as organ donors. In section five, I discuss the role of the child in the decision-making process. In section six, I critically examine the criteria for equity in donor selection. (shrink)

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in (...) the AIDS epidemic. These social forces have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults. (shrink)

OBJECTIVE: To apply component analysis, a structured approach to the ethical analysis of risks and potential benefits in research, to published emergency research using a waiver of/exception from informed consent. The hypothesis was that component analysis could be used with a high degree of interrater reliability, and that the vast majority of emergency research would comply with a minimal-risk threshold. METHODS: A Medline search and manual search were done to identify studies using a waiver of/exception from informed consent published between (...) July 1996 and December 2000. A review panel of physicians and bioethicists independently classified nontherapeutic procedures in each study as minimal risk, probably minimal risk, or probably more than minimal risk. RESULTS: Seventy studies using a waiver of/exception from informed consent were identified. A majority of reviewers classified nontherapeutic procedures in 62 studies (88.6%) as minimal risk. Reviewers classified nontherapeutic procedures in six studies (8.6%) as minimal risk or probably minimal risk. In two studies (2.9%), nontherapeutic procedures were classified as probably more than minimal risk. The intraclass correlation coefficient was 0.89 (95% CI = 0.85 to 0.93), indicating very high interrater reliability. CONCLUSIONS: Component analysis can be used with high reliability to review emergency research and may improve the consistency of institutional review board review of emergency research. The vast majority of published emergency research performed using a waiver of/exception from consent complies with a properly-applied minimal-risk threshold. A minimal-risk threshold for nontherapeutic procedures protects subjects better than current U.S. regulations while permitting important emergency research to continue. (shrink)

Definition of the problem: The differentiation between ”therapeutic” and ”non-therapeutic” research has found broad acceptance within clinical research, law and medical ethics and is part of national law and international declarations. However, this terminology is problematic on the medical (descriptive) as well as on the ethical (normative) level. Arguments: On theoretical grounds and with an example from clinical practice it is argued that e.g. the terms ”therapeutic research” and ”experimental treatment” are rather manipulative to the patient. Conclusion: In obtaining informed (...) consent from human subjects in medical research the individual risk-benefit-assessment should be pointed out clearly rather than arguing in the category of ”therapeutic” versus ”non-therapeutic” research. (shrink)